Actively Recruiting
A Study to Evaluate Safety, Tolerability, Efficacy, Pharmacokinetics and Pharmacodynamics of CNK-UT Cells for Steroid-Refractory or Steroid-Dependent Graft-versus-Host Disease
Led by Fujian Medical University · Updated on 2024-08-23
17
Participants Needed
1
Research Sites
34 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a new treatment using universal T-cells engineered with a chimeric natural killer receptor (CNK-UT) for patients who have graft-versus-host disease (GVHD) that is resistant or dependent on steroids. This study is a phase I, open-label, single-arm trial designed to assess the safety, tolerability, and effectiveness of CNK-UT cells in patients who have not responded to standard treatments including ruxolitinib or other second-line medications. The study also aims to understand how these cells behave in the body through pharmacokinetic and pharmacodynamic assessments. The treatment involves two study stages: dose escalation and dose expansion. In the dose escalation phase, participants receive a single intravenous infusion of CNK-UT cells at increasing doses to determine the maximum tolerated dose and observe any dose-limiting toxicities over 21 days. If tolerated, participants move to the dose expansion phase where multiple doses of CNK-UT cells are given, with dosing and frequency adjusted based on earlier results. This approach allows researchers to study both safety and potential benefits of repeated dosing. Participants will be closely monitored throughout the study with assessments including adverse event tracking up to one year, response evaluations over six months, and blood tests to measure immune cell levels and drug behavior up to 48 weeks. The primary outcomes focus on safety signals and maximum tolerated dose, while secondary outcomes include measures of treatment response, survival, and drug kinetics. The total study duration includes active treatment periods and long-term follow-up to ensure comprehensive evaluation of the therapy's impact.
CONDITIONS
Brief Title
Chimeric Natural Killer Receptor-Universal T Cells for Refractory GVHD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 1 to 70 years, male or female
- Diagnosed with grade II to IV steroid-refractory, steroid-resistant, or steroid-dependent graft-versus-host disease after allogeneic stem cell transplantation
- Failed treatment with ruxolitinib or at least one other second-line medication, or intolerant to these medications
- ECOG physical status score between 0 and 3
- Estimated life expectancy greater than 12 weeks
- For females of childbearing age, a negative pregnancy test before enrollment and agreement to use effective contraception during the trial; males with partners of childbearing age must use contraception during the study and for at least 6 months after the last dose
- Voluntarily agree to participate, understand the study, sign informed consent, and follow all procedures
You will not qualify if you...
- History of malignant tumors within 5 years before enrollment, except certain skin and thyroid cancers and treated carcinoma in situ
- History of organ transplantation
- Previously undergone more than one allogeneic hematopoietic stem cell transplantation
- Uncontrolled hypertension, symptomatic congestive heart failure (NYHA III-IV), poorly controlled arrhythmias, congenital long QT syndrome, or QTc over 500 ms
- Unstable systemic diseases requiring pharmacological treatment, excluding transplant complications
- Active pulmonary tuberculosis or recent anti-tuberculosis treatment, HIV infection, or known syphilis infection
- Severe active or poorly controlled infections
- Participation in other clinical trials within 12 weeks prior to study start
- Previous use of any gene therapy products
- Allergy to components of CNK-UT injection
- Known mental or substance abuse disorders affecting compliance
- Pregnant or breastfeeding women, or plans for birth within 1 year after treatment
- Uncontrolled metabolic or non-malignant organ/systemic diseases increasing medical risk
- Any condition investigator deems unsuitable for study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 year
Participants receive CNK-UT cells therapy by intravenous infusion. This includes a dose escalation phase with a single dose followed by a dose expansion phase with multiple doses based on results from dose escalation.
Visits for dosing and safety monitoring during dose escalation and dose expansion phases
Duration - Up to 48 weeks
Participants are monitored for safety, efficacy, and pharmacokinetics of CNK-UT cells after treatment completion.
Regular visits for up to 48 weeks after last dose
Trial Site Locations
Total: 1 location
1
First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China
Actively Recruiting
Research Team
T
Ting YANG, Prof.
J
Jianda HU, Prof.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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